Proprietary Laboratory Analyses (PLA) codes serve as unique identifiers within the healthcare system for billing specialized laboratory tests. These codes allow a specific laboratory or manufacturer to clearly distinguish its unique, proprietary test from other similar services. The creation of these distinct codes addresses the challenge of accurately reporting and tracking modern, complex diagnostic technologies that do not fit the description of standard, common lab procedures. By providing a standardized, clear descriptor for a test, PLA codes help to streamline the administrative process for both the laboratory that developed the test and the payer that is asked to cover it.
Where PLA Codes Fit in Medical Billing
PLA codes are a specific type of alphanumeric code within the larger structure of Current Procedural Terminology (CPT) codes, which are developed and maintained by the American Medical Association (AMA). Standard CPT codes, often referred to as Category I codes, cover the vast majority of medical procedures and services performed across the healthcare system. Because innovation in laboratory science often outstrips the standard CPT update cycle, a more flexible system was needed to recognize novel tests quickly.
These proprietary codes are easily recognized by their structure, consisting of four numbers followed by the letter “U,” typically falling in the 0001U to 0999U series. This unique alphanumeric designation separates them from traditional Category I CPT codes, which are strictly numeric. The AMA CPT Editorial Panel manages these codes, placing them in a specific subsection of the Pathology/Laboratory CPT codes. The existence of a PLA code means a specific proprietary test can be precisely identified on a claim form, rather than being grouped with a more generic or “unlisted” procedure code.
The Types of Laboratory Tests They Cover
PLA codes were created primarily to provide unique billing identifiers for tests that are proprietary to a single laboratory or manufacturer. These specialized tests often represent the cutting edge of diagnostic medicine, utilizing complex technologies that analyze multiple biomarkers simultaneously. They are frequently used to report Advanced Diagnostic Laboratory Tests (ADLTs) and Clinical Diagnostic Laboratory Tests (CDLTs), as defined under federal regulations.
The scope of these tests includes complex services such as Multianalyte Assays with Algorithmic Analyses (MAAA), where the results of multiple measurements are combined using a proprietary mathematical formula to produce a single result, often a risk score. PLA codes are also widely used for tests involving Genomic Sequencing Procedures (GSP), which include comprehensive genetic panels for cancer, hereditary disorders, and pharmacogenomics. For example, a PLA code might be assigned to a specific test that analyzes a tumor sample’s DNA and RNA to predict a patient’s response to a targeted chemotherapy drug.
How New PLA Codes Are Established
A laboratory or manufacturer seeking a PLA code must submit an application to the AMA CPT Editorial Panel, which manages the process. The application must demonstrate that the test is commercially available in the United States, performed on human specimens, and is unique or proprietary to the requesting entity. Required documentation includes the test’s Standard Operating Procedures (SOPs), which detail every step of the analytic process.
The application undergoes a rigorous, multi-step review process to ensure the test meets the criteria for a unique code. This review includes an evaluation by the Proprietary Laboratory Analyses Technical Advisory Group (PLA-TAG), which assesses the scientific merit and proprietary claim of the test. The CPT Editorial Panel then discusses the application in public, quarterly meetings, eventually voting on the assignment of a new code. If approved, the new code is published in a quarterly update, ensuring the coding system remains current with scientific advancement.
Impact on Patient Costs and Coverage
The existence of a PLA code provides a necessary mechanism for laboratories to bill for their specialized tests, but it does not automatically guarantee that a patient’s insurance will cover the cost. Insurance payers, including Medicare and private companies, must still determine the medical necessity of the test for a specific patient’s condition. For many new PLA codes, particularly those representing novel diagnostics, a payer may initially consider the test experimental or investigational due to a lack of long-term clinical outcome data.
Because these tests are highly specialized and often involve advanced technology, their cost can be significantly higher than common lab work. Payers frequently require prior authorization before the test is performed. If a test is deemed not medically necessary or is still considered investigational by a patient’s insurer, the patient may be responsible for a substantial portion or even the full cost of the proprietary analysis.